PDF-CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:205858Orig1s

OFFICE DIRECTOR MEMO Office Director Summary Review NDA 205858 Zydelig idelalisib On September 11 2013 Gilead Sciences Inc submitted an NDA for Zydelig idelalisib for the proposed indication. DFXED LYLVLRQ57347RI57347DVWURHQWHURORJ DQG57347QERUQ57347UURU 3URGXFWV LFKDUG5734757355HV5735657347VKLKDUD ULDQ573476W URQJLQ LYLVLRQ57347RI 3XOPRQDU OOHUJ 5735957347DQG573475KHXPDWRORJ 3URGXFWV 6DQG57347DUQHV LYLVLRQ57347RI573470HWDEROLVP57347DQ 6 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice Management of Breakthrough TherapyDesignated Drugs and Biologics Table of Contents PURPOSE 1 BACKGROUND Center for Drug Evaluation and ResearchU.S. Food and Drug Administration U.S. Health and Human Services Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDA’s Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 dr ilable from: Dsion of Drug Information 101 New Hampshire Ave. 0993 1-847-8714 ov yInformation/Guidances/default.htmAdditional copies are avaOffice of Communications iviSilver Spring, MD 2Phone: 301- U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Translational Sciences Office of BiostatisticsTATISTICAL EVIEW AND VALUATIO Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg. 51, Room Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 dr Additional copies are available from Office of Communications Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave Hillandale Bldg NDA 206353 ATV/COBI FDC CDTL Review mentioned phase III trialand a phase IItrialTrialGS-US-216-0105 as reviewed in NDA The findings of this study was extrapolatedto HIV-1treatment-experienced patients Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B